Zdrowie i gospodarka · 04/03/2010

FDA Releases Guidance for Industry on Cell Substrates and Biological Materials for Viral Vaccines

The Food and Drug Administration (FDA) has released a guidance document providing recommendations for the characterization and qualification of cell substrates and biological materials used in the production of viral vaccines for human use. This document finalizes a previous draft and replaces previous guidance on viral vaccines for infectious disease prevention and treatment.